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A Study of Semagacestat for Alzheimer's Patients (Identity XT)

2014년 9월 22일 업데이트: Eli Lilly and Company

Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)

The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF).

Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.

연구 개요

상태

완전한

정황

알츠하이머병

개입 / 치료

의약품: semagacestat

연구 유형

중재적

등록 (실제)

180

단계

3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

남아프리카
- - Bellville, 남아프리카, 7530
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독일
- - Hannover, 독일, 30559
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  - Muenchen, 독일, 81675
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  - Regensburg, 독일, D-93053
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  - Siegen, 독일, 57072
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미국
- Arizona
  - Phoenix, Arizona, 미국, 85004
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  - Sun City, Arizona, 미국, 85351
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  - Tucson, Arizona, 미국, 85741
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- California
  - Costa Mesa, California, 미국, 92626
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  - Fresno, California, 미국, 93720
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  - Laguna Hills, California, 미국, 92653
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  - Lomita, California, 미국, 90717
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  - Orange, California, 미국, 92868
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  - San Diego, California, 미국, 92103
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  - San Francisco, California, 미국, 94109
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  - Santa Monica, California, 미국, 90404
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- Connecticut
  - Hamden, Connecticut, 미국, 06518
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  - New Haven, Connecticut, 미국, 06510
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- District of Columbia
  - Washington, District of Columbia, 미국, 20057
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- Florida
  - Brooksville, Florida, 미국, 34601
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  - Deerfield Beach, Florida, 미국, 33064
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  - Fort Lauderdale, Florida, 미국, 33308
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  - Fort Myers, Florida, 미국, 33912
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  - Hollywood, Florida, 미국, 33021
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  - Miami, Florida, 미국, 33137
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  - Orlando, Florida, 미국, 32806
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  - St Petersburg, Florida, 미국, 33716
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  - Tampa Bay, Florida, 미국, 33613
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- Indiana
  - Indianapolis, Indiana, 미국, 46202
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- Kentucky
  - Lexington, Kentucky, 미국, 40503
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- Louisiana
  - New Orleans, Louisiana, 미국, 70131
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  - Shreveport, Louisiana, 미국, 71104
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- Massachusetts
  - Hyannis, Massachusetts, 미국, 02601
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- Missouri
  - St Louis, Missouri, 미국, 63108
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- New York
  - New York, New York, 미국, 10032
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- North Carolina
  - Durham, North Carolina, 미국, 27705
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  - Raleigh, North Carolina, 미국, 27607
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  - Winston-Salem, North Carolina, 미국, 27103
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- Ohio
  - Toledo, Ohio, 미국, 43623
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- Oklahoma
  - Oklahoma City, Oklahoma, 미국, 73116
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- Oregon
  - Eugene, Oregon, 미국, 97401
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- Pennsylvania
  - Jenkintown, Pennsylvania, 미국, 19046
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  - Philadelphia, Pennsylvania, 미국, 19104
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- Rhode Island
  - East Providence, Rhode Island, 미국, 02914
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- South Carolina
  - North Charleston, South Carolina, 미국, 29406
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- Vermont
  - Bennington, Vermont, 미국, 05201
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스웨덴
- - Stockholm, 스웨덴, 14186
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스페인
- - Barcelona, 스페인, 08003
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  - Plasencia, 스페인, 10600
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이스라엘
- - Ashkelon, 이스라엘, 78306
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  - Petah Tikva, 이스라엘, 49100
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  - Tel Hashomer, 이스라엘, 52661
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이탈리아
- - Milano, 이탈리아, 20132
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일본
- - Fukui, 일본, 910-3113
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  - Fukuoka, 일본, 770-8076
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  - Kochi, 일본, 780-0842
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  - Tokushima, 일본, 770-0852
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칠레
- - Antofagasta, 칠레
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  - Santiago, 칠레
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  - Valdivia, 칠레
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캐나다
- British Columbia
  - Kelowna, British Columbia, 캐나다, V1Y3G8
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  - Penticton, British Columbia, 캐나다, V2A5C8
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- Quebec
  - Sherbrooke, Quebec, 캐나다, J1H1Z1
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폴란드
- - Lublin, 폴란드, 20-950
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  - Poznan, 폴란드, 61- 485
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프랑스
- - Toulouse, 프랑스, TSA 60033
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핀란드
- - Kuopio, 핀란드, 70210
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  - Oulu, 핀란드, 90229
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호주
- New South Wales
  - Kogarah, New South Wales, 호주, 2217
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- Victoria
  - Geelong, Victoria, 호주, 3220
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  - Heidelberg West, Victoria, 호주, 3081
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참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
Completed semagacestat study LFAN or study LFBC through 88 weeks
Must continue to have a reliable caregiver
Capable of swallowing whole oral medication
Agrees not to participate in other investigational compounds for the duration of study

Exclusion Criteria:

Meets LFAN or LFBC study discontinuation criteria at the last visit of the LFAN or LFBC study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 해당 없음
중재 모델: 단일 그룹 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Drug: semagacestat	의약품: semagacestat 140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability 다른 이름들: LY450139

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug 기간: Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug	The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.	Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug 기간: Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug	The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.	Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 12월 1일

기본 완료 (실제)

2011년 4월 1일

연구 완료 (실제)

2011년 4월 1일

연구 등록 날짜

최초 제출

2009년 12월 17일

QC 기준을 충족하는 최초 제출

2009년 12월 17일

처음 게시됨 (추정)

2009년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 9월 22일

마지막으로 확인됨

2014년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

5930
H6L-MC-LFBF (기타 식별자: Eli Lilly and Company)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

알츠하이머병에 대한 임상 시험

L2 Bio, LLC
FDAMap; Akan Biosciences, Inc.

아직 모집하지 않음

크론 병 환자에서 L2-01의 안전성 및 효능을 평가하기위한 이중 맹검, 무작위 위약 대조 II 상 임상 시험

Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
Takeda

모병

본 빌레브란트병(vWD)을 가진 소아 환자를 대상으로 보니코그 알파(rVWF)에 대한 관찰 연구

Von Willebrand Disease (vWD)

일본
Vanderbilt University Medical Center
Takeda Pharmaceuticals U.S.A., Inc.

모집하지 않고 적극적으로

염증성 장 질환에 대한 정맥 내에서 피하 베 딜리 주맙으로의 이동 평가

염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)

미국
University of Pennsylvania

모집하지 않고 적극적으로

이전에 치료받은 특발성 다발성 캐슬맨병에서의 Sirolimus

캐슬맨병 | 캐슬맨병, 다발성

미국
Kaohsiung Medical University

아직 모집하지 않음

ADH1B 및 ALDH 유전자 변이와 폐암 위험 (ALDH)

폐 선암종 | 폐암(진단) | Condition/Disease
Nandakumar Narayanan
National Institute of Neurological Disorders and Stroke (NINDS)

초대로 등록

중간 전면 델타/세타 및인지 제어

Parkinson & amp; amp;#39; s Disease (PD)

미국
UNC Lineberger Comprehensive Cancer Center
Fogarty International Center of the National Institute of Health

모집하지 않고 적극적으로

말라위에서 다발성 캐슬만병 치료를 위한 Rituximab의 안전성 및 유효성

다발성 캐슬맨병

말라위
Novartis Pharmaceuticals

모병

류마티스 관절염 및 Sjogren 's Disease에서 Rapcabtagene autoleucel의 안전성, 세포 동역학 및 탐색 효능을 평가하는 연구

류마티스 관절염 (RA) 및 Sjögren 's Disease (SJD)

스페인, 프랑스, 독일, 싱가포르
University of Pennsylvania
EUSA Pharma, Inc.; Castleman Disease Collaborative Network

모병

캐슬만병 환자를 위한 국제 등록부 (ACCELERATE)

캐슬맨병 | 캐슬맨병 | 거대 림프절 과형성 | 혈관여포 림프 증식증 | 혈관여포 림프절 과형성 | 혈관여포성 림프종 과형성 | GLNH | 과형성, 거대 림프절 | 림프절 과형성, 거인

미국
Jiulongpo No.1 People's Hospital
Jiangxi Maternal and Child Health Hospital

아직 모집하지 않음

매우 조산아의 RD에 대한 NIPPV에 따라 Fio₂> 0.25에서 조기 계면 활성제 투여

호흡기 고통 증후군 (& amp; [hyaline embrane disease])

중국

결과 측정	측정값 설명	기간
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12 기간: Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)	Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.	Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)
Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 12 weeks (LFBF)
Mean Concentration of LY450139 기간: 3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)		3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug 기간: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug	ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.	Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug 기간: Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug	The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.	Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug
Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24 기간: Baseline (LFAN Randomization), 24 weeks (LFBF)	The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 24 weeks (LFBF)
Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24 기간: Baseline (LFAN Randomization), 24 weeks (LFBF)	The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 24 weeks (LFBF)
Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24 기간: Baseline (LFAN Randomization), 24 weeks (LFBF)	The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.	Baseline (LFAN Randomization), 24 weeks (LFBF)
Change From Baseline in EuroQol-5D (EQ-5D) at Week 24 기간: Baseline (LFAN Randomization), 24 weeks (LFBF)	EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.	Baseline (LFAN Randomization), 24 weeks (LFBF)
Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12 기간: Baseline (LFAN Randomization), 12 weeks (LFBF)	RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.	Baseline (LFAN Randomization), 12 weeks (LFBF)

A Study of Semagacestat for Alzheimer's Patients (Identity XT)

Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)

연구 개요

상태

정황

개입 / 치료

연구 유형

등록 (실제)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

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개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

연구 기록 날짜

연구 주요 날짜

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기본 완료 (실제)

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최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (추정)

연구 기록 업데이트

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QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

알츠하이머병에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Georgia

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약물 개입

식이 보충제

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